BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM

    MDR report key: 6691631 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04588
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 6, 2017
    Report Date
    October 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THIS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: SCREW CATALOG#: 115383 LOT#: 552680, SCREW CATALOG#: 180500 LOT#: 836390, SCREW CATALOG#: 180500 LOT#: 669780, SCREW CATALOG#: 180501 LOT#: 730570, SCREW CATALOG#: 180502 LOT#: 605670, GLENOSPHERE CATALOG#: 115320, LOT#: 890140, PIN CATALOG#: 405800 LOT#: 914650, DRILL CATALOG#: 405889 LOT#: 209110, DRILL CATALOG#: 405883 LOT#: 316690, TAPER CATALOG#: 118001 LOT#: 927470, BASEPLATE CATALOG#: 115330 LOT#: 926700, BEARING CATALOG#: XL-115366 LOT#: 585890, EXTRACT CATALOG#: 110028441 LOT#: UNK, TRAY CATALOG#: 115340 LOT#: 983880. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04550, 0001825034-2017-04590.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE, THE TAPER FROM THE FRACTURED HUMERAL TRAY WAS STUCK IN THE STEM AND THE REMOVAL TOOL WAS NOT ABLE TO REMOVE IT AFTER SEVERAL ATTEMPTS. AS A RESULT, IT BECAME NECESSARY TO REMOVE THE HUMERAL STEM. DURING STEM REMOVAL, THE STEM EXTRACTOR INSTRUMENT FRACTURED. THE SURGERY WAS COMPLETED BY USING A SMALL DRILL BIT TO REMOVE BONE FROM THE PROXIMAL END OF THE STEM AND USED VICE GRIPS TO REMOVE THE STEM. A NEW STEM OF THE SAME SIZE AND A +5 BEARING AND NEW TRAY WERE IMPLANTED TO COMPLETE THE PROCEDURE. THIS MALFUNCTION ENDED UP CAUSING AN APPROXIMATE DELAY OF THIRTY FIVE (35) TO FORTY FIVE (45) MINUTES IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471373 COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 423170

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R